Course Description

Designing a Strategic Medical Device Clinical Investigation Plan/Protocol

Course Description:

This course focuses on designing thorough clinical investigation plans using a logical, step-by-step approach. It covers basic strategic claims, how to develop a design so that it translates valid and feasible endpoints, and guidance and regulatory documents and requirements to ensure that the final results are aligned with market needs.

Watch the Course Trailer:

 

 


Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Define claims as starting points for study designs
  • Interpret the information found in guidance and regulatory documents and plan an appropriate study design for a future medical device investigation
  • Implement feasible methods for realistic endpoints
  • Build clinical investigation plan designs that are acceptable to investigators, patients, and regulators

Who Should Enroll:

Clinical project directors, managers, and senior regulatory managers are all encouraged to enroll in this course.


Prerequisite Knowledge/Requirements:

The following courses are required:

  • ISO 14155: In-Depth Review (series; IDs 61–67)
  • The European Union Regulatory System for Medical Devices (ID 145)
  • The Japanese Regulatory System for Medical Devices (ID 146)
  • US FDA 510(k) Notification Process (ID 92)
  • US FDA Investigational Device Exemption (IDE) Overview (ID 121)

Subject Matter Expert:
Catherine Kusnick
Danielle Giroud

Duration:
90 min

Release date:
05/14/2012

Related resources:
Yes

Case studies:
No

Price:
Basic Account: € 454.00
Premium Account: € 341.00

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